The European Medicines Agency revised its guideline on first-in-human clinical trials, highlighting the sponsor’s responsibility for mitigating risks to volunteers.in the study design. Source: Drug Industry Daily

Missouri Gov. Eric Greitens (R) directed his health department to begin building a state prescription drug monitoring program to track prescribing and dispensing of several controlled drugs, including opioids. Source:…

In the first trial verdict of thousands of similar suits, a federal jury ordered AbbVie to pay $150 million to a man who claimed the company’s testosterone drug AndroGel caused…

With just over two months left in the program, the FDA finalized a question-and-answer guidance for GDUFA I, covering ANDA reviews, inspections and self-identification of facilities. Source: Drug Industry Daily